亚洲口服抗凝药物治疗的心房颤动患者中 HAS-BLED、GARFIELD-AF 和 ORBIT 出血风险评分的比较验证：来自 COOL-AF 登记处的报告。
Comparative validation of HAS-BLED, GARFIELD-AF and ORBIT bleeding risk scores in Asian people with atrial fibrillation treated with oral anticoagulant: A report from the COOL-AF registry.
机构信息
Cardiology Unit, Division of Internal Medicine, Faculty of Medicine, Prince of Songkla University, Songkhla, Thailand.
Division of Cardiology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.
出版信息
Br J Clin Pharmacol. 2023 Aug;89(8):2472-2482. doi: 10.1111/bcp.15716. Epub 2023 Apr 4.
AIMS
Comparative data between the HAS-BLED, GARFIELD-AF and ORBIT score are limited in anticoagulated Asian patients with atrial fibrillation (AF). We compared the performance of the 3 scores in a nationwide registry.
METHODS
AF patients treated with oral anticoagulants in the COOL-AF registry were studied. We fitted the variables of the HAS-BLED, GARFIELD-AF and ORBIT score to major bleeding in Cox model. We explored a modified HAS-BLED by addition of sex and body weight. Discrimination, calibration, net reclassification index (NRI) and decision curve analysis were used to compare the performance of the 3 models.
RESULTS
Of 3402 patients in the registry, 2568 patients who received oral anticoagulant at baseline were studied. Majority of patients (91.1%) received warfarin. The rate of major bleeding was 2.11 per 100 person-years. The C-statistics of the GARFIELD-AF, HAS-BLED, modified HAS-BLED and ORBIT score were 0.65 (95% confidence interval [CI] 0.63-0.67), 0.66 (95%CI 0.64-0.68), 0.69 (95%CI 0.67-0.71) and 0.64 (95%CI 0.62-0.66) respectively. There was good agreement between predicted and observed bleeding in the deciles of HAS-BLED and GARFIELD-AF scores, while the modified HAS-BLED score and ORBIT score overestimated the risk in the last decile. The modified HAS-BLED score had superior NRI than the HAS-BLED score (26.9%, 95%CI 9.7%-42.2%) and the ORBIT score (31.9%, 95%CI 9.0-53.6%). The NRI between the modified HAS-BLED and GARFIELD-AF score was similar. The net benefit curve of the 4 models were overlapping among different thresholds.
CONCLUSIONS
The clinical utility for bleeding prediction of GARFIELD-AF, HAS-BLED, modified HAS-BLED and ORBIT scores were similar in anticoagulated Asian patients with AF participating in the COOL-AF registry. We found no advantage of the ORBIT over HAS-BLED score for bleeding risk prediction, even in direct oral anticoagulant users.
目的
在接受抗凝治疗的亚洲心房颤动（房颤）患者中，HAS-BLED、GARFIELD-AF 和 ORBIT 评分之间的比较数据有限。我们在全国性注册研究中比较了这 3 种评分的表现。
方法
在 COOL-AF 注册研究中，研究了接受口服抗凝剂治疗的房颤患者。我们将 HAS-BLED、GARFIELD-AF 和 ORBIT 评分的变量拟合到 Cox 模型中的大出血中。我们通过添加性别和体重来探索改良的 HAS-BLED。使用判别、校准、净重新分类指数（NRI）和决策曲线分析来比较这 3 种模型的性能。
结果
在该注册研究的 3402 例患者中，对基线时接受口服抗凝剂治疗的 2568 例患者进行了研究。大多数患者（91.1%）接受华法林治疗。大出血的发生率为每 100 人年 2.11 例。GARFIELD-AF、HAS-BLED、改良 HAS-BLED 和 ORBIT 评分的 C 统计量分别为 0.65（95%置信区间 [CI] 0.63-0.67）、0.66（95%CI 0.64-0.68）、0.69（95%CI 0.67-0.71）和 0.64（95%CI 0.62-0.66）。在 HAS-BLED 和 GARFIELD-AF 评分的十分位数中，预测出血与观察出血之间存在良好的一致性，而改良 HAS-BLED 评分和 ORBIT 评分高估了最后十分位数的风险。改良 HAS-BLED 评分的 NRI 优于 HAS-BLED 评分（26.9%，95%CI 9.7%-42.2%）和 ORBIT 评分（31.9%，95%CI 9.0-53.6%）。改良 HAS-BLED 与 GARFIELD-AF 评分之间的 NRI 相似。4 种模型的净获益曲线在不同阈值之间存在重叠。
结论
在参与 COOL-AF 注册研究的接受抗凝治疗的亚洲房颤患者中，GARFIELD-AF、HAS-BLED、改良 HAS-BLED 和 ORBIT 评分对出血预测的临床应用价值相似。我们没有发现 ORBIT 评分在出血风险预测方面优于 HAS-BLED 评分的优势，即使在直接口服抗凝剂使用者中也是如此。
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